Malaria Prevention Cambodia (MPC)
This study has suspended participant recruitment.
(Medication safety concern)
Sponsor:
Armed Forces Research Institute of Medical Sciences, Thailand
Collaborators:
National Center for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
United States Army Medical Materiel Development Activity
Information provided by (Responsible Party):
David Saunders, Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier:
NCT01624337
First received: June 17, 2012
Last updated: June 19, 2012
Last verified: June 2012
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Purpose
Trial of monthly DHA-piperaquine for malaria prevention in health volunteers.
| Condition | Intervention |
|---|---|
|
Malaria |
Drug: DHA-piperaquine Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double Blind, Placebo-controlled Clinical Trial of Monthly DHA-piperaquine for Malaria Prevention in Cambodia. |
Resource links provided by NLM:
Further study details as provided by Armed Forces Research Institute of Medical Sciences, Thailand:
Primary Outcome Measures:
- Protective efficacy [ Time Frame: 4 months ] [ Designated as safety issue: No ]
To quantify protective efficacy for the prevention of malaria infection in a setting of mixed multidrug resistant P. falciparum and P. vivax malaria, particularly in non-immune volunteers, in two treatment groups - monthly DHA-piperaquine vs. placebo.
Protective efficacy will be defined by reduction in the incidence of malaria between treatment and placebo groups.
Secondary Outcome Measures:
- Cardiac safety of piperaquine as determined by QT interval prolongation [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]To document the effect on the electrocardiogram (EKG), particularly the QTc interval, in patients taking repeated monthly treatment courses of DHA-piperaquine.
| Estimated Enrollment: | 231 |
| Study Start Date: | May 2012 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DHA-piperaquine
DHA-piperaquine monthly 2 day treatment course
|
Drug: DHA-piperaquine
Drug: Dihydroartemisinin piperaquine 40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day) Other Name: Duocotexcin
|
|
Placebo Comparator: Placebo
Matching placebo control
|
Drug: placebo |
Detailed Description:
This is a two arm, randomized, double-blind, placebo controlled cohort study to determine the protective efficacy of a monthly 2 day treatment course of Dihydroartemisinin-Piperaquine (DP) in adult volunteers in malaria endemic areas of Cambodia.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Volunteer 18-65 years of age
- Able to give informed consent
- Likely to reside in malaria endemic area for the duration of the study
- Available for follow-up for anticipated study duration, and agrees to participate for the duration of the study
- Agrees not to seek outside medical care for febrile illness, except in emergency situations, unless referred by study team
- Authorized by local commander to participate in the study if on active duty
Exclusion Criteria:
- Known allergy or other contraindication to DHA, piperaquine treatment, and/or primaquine treatment
- Significant acute comorbidity requiring urgent medical intervention
- Positive malaria blood smear.
- Treatment with an antimalarial drug in the past 30 days.
- Pregnant or lactating female or a female of childbearing age who does not agree to use a highly effective method of birth control during the study
- Significantly abnormal EKG including a QTcF interval greater than 450ms at baseline (or 470ms for females) using Fridericia's correction
- Regular current use of known QTc prolonging medications
- History of sudden cardiac death in an immediate family member, or personal history of known symptomatic coronary artery disease or arrhythmias
- Judged by the investigator to be otherwise unsuitable for study participation or non-compliant with study requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624337
Locations
| Cambodia | |
| Anlong Veng Referral Hospital | |
| Anlong Veng, Oddar Meancheay, Cambodia | |
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
National Center for Parasitology, Entomology and Malaria Control, Cambodia
Royal Cambodian Armed Forces
United States Army Medical Materiel Development Activity
Investigators
| Principal Investigator: | DAVID SAUNDERS, MD, MPH | Armed Forces Research Institute of Medical Sciences, Thailand |
| Principal Investigator: | Chanthap Lon, MD | Armed Forces Research Institute of Medical Sciences, Thailand |
More Information
No publications provided
| Responsible Party: | David Saunders, Chief, Department of Immunology and Medicine, Armed Forces Research Institute of Medical Sciences, Thailand |
| ClinicalTrials.gov Identifier: | NCT01624337 History of Changes |
| Other Study ID Numbers: | WRAIR # 1849, A-17057 |
| Study First Received: | June 17, 2012 |
| Last Updated: | June 19, 2012 |
| Health Authority: | Cambodia: Ministry of Health |
Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
|
Plasmodium falciparum Plasmodium vivax |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Piperaquine Antimalarials |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013